The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy

NCT ID: NCT01691716

Last Updated: 2014-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of this study is to determine whether Tendoactive, eccentric training, or the combination or both could be effective in the treatment of Achilles tendinopathy.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tendoactive

Tendoactive dosage: 3 capsules per day

Group Type: EXPERIMENTAL

Tendoactive

Intervention Type: DRUG

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

Eccentric training

Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Group Type: ACTIVE_COMPARATOR

Eccentric training

Intervention Type: BEHAVIORAL

Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Tendoactive and eccentric training

Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Group Type: ACTIVE_COMPARATOR

Tendoactive

Intervention Type: DRUG

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

Eccentric training

Intervention Type: BEHAVIORAL

Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Interventions

Tendoactive

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

Intervention Type: DRUG

Eccentric training

Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 3 months (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation).
• Men and non-pregnant women aged 18-70 years
• Be informed of the nature of the study and provide written informed consent.

Exclusion Criteria

• Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
• Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
• Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
• Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
• Clinical suspicion of peroneal subluxation
• Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
• Condition that prevents the patients from executing an active exercise programme
• Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
• Patient has already received an injection of PRP for this injury
• Patient does not wish, for whatever reason, to undergo one of the two treatments
• Known presence of a pregnancy
• Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioiberica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMI

Barcelona, Barcelona, Spain

CEARE

Esplugues de Llobregat, Barcelona, Spain

Clínica CEMTRO

Madrid, Madrid, Spain

AMS - Centro de Ejercicio

Málaga, Malaga, Spain

Centro de Medicina y Deporte

Toledo, Toledo, Spain

Clínica Traumatológica

Valladolid, Valladolid, Spain

Countries

Spain

References

Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.

Reference Type: BACKGROUND

PMID: 9617396 (View on PubMed)

Balius R, Alvarez G, Baro F, Jimenez F, Pedret C, Costa E, Martinez-Puig D. A 3-Arm Randomized Trial for Achilles Tendinopathy: Eccentric Training, Eccentric Training Plus a Dietary Supplement Containing Mucopolysaccharides, or Passive Stretching Plus a Dietary Supplement Containing Mucopolysaccharides. Curr Ther Res Clin Exp. 2016 Nov 18;78:1-7. doi: 10.1016/j.curtheres.2016.11.001. eCollection 2016.

Reference Type: DERIVED

PMID: 28053674 (View on PubMed)

Other Identifiers

PRJ-00014

Identifier Type: -

Identifier Source: org_study_id